Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis (EEPAB)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00505128
First received: July 20, 2007
Last updated: May 6, 2011
Last verified: May 2007

July 20, 2007
May 6, 2011
July 2007
July 2009   (final data collection date for primary outcome measure)
Percentage of patients cured or consolidated as a function of time [ Time Frame: during 12 months ] [ Designated as safety issue: Yes ]
Percentage of patients cured or consolidated as a function of time [ Time Frame: during 12 months ]
Complete list of historical versions of study NCT00505128 on ClinicalTrials.gov Archive Site
  • overall morbidity [ Time Frame: during the 36 months ] [ Designated as safety issue: Yes ]
  • overall mortality [ Time Frame: during the 36 months ] [ Designated as safety issue: Yes ]
  • endoscopic procedure-related morbidity and mortality [ Time Frame: during the 12months ] [ Designated as safety issue: Yes ]
  • LOS [ Time Frame: during the 12 months ] [ Designated as safety issue: Yes ]
  • morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies) [ Time Frame: during the 12 months ] [ Designated as safety issue: Yes ]
  • economic data [ Time Frame: during the 36 months ] [ Designated as safety issue: Yes ]
  • overall morbidity [ Time Frame: during the 36 months ]
  • overall mortality [ Time Frame: during the 36 months ]
  • endoscopic procedure-related morbidity and mortality [ Time Frame: during the 12months ]
  • LOS [ Time Frame: during the 12 months ]
  • morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies) [ Time Frame: during the 12 months ]
  • economic data [ Time Frame: during the 36 months ]
Not Provided
Not Provided
 
Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis
Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis: a Prospective Multicenter Randomized Controlled Study

Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.

Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.

Main objective: to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography.

Prospective multicenter randomized controlled study with direct patient benefit

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Biliary Pancreatitis
Procedure: Endoscopic sphincterotomy
procedure
Other Name: procedure
1
to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography
Intervention: Procedure: Endoscopic sphincterotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
900
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Previous medical examination
  • Age over 18
  • Acute biliary pancreatitis
  • Timespan between onset of symptoms and randomization <72h
  • No involvement in another clinical study
  • Informed consent obtained

Exclusion Criteria:

  • Non biliary pancreatitis
  • Age < 18
  • Timespan between onset of symptoms and randomization >72h
  • No follow-up possible beyond 3 months after inclusion
  • Ongoing pregnancy
  • No informed consent
  • No health insurance affiliation
  • Involvement in another clinical study
  • Incapacity to understand subject information
  • Counter indication of MRI examination if echo-endoscopy is not available
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00505128
P051054
No
Cecile jourdain, Department of Clinical Research of developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Frederic PRAT, MD, Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP